Manufacturing Process and Traceability

Facilitated transition of research oligos to GMP-certified oligos for diagnostics

IDT offers the highest standards of traceability for custom GMP manufacturing of molecular diagnostics. The controlled and validated process is governed by IDT’s Oligo Master Record (OMR). This document is our collaborative playbook for how we produce your oligos, every time, all the time.

Define and control all aspects of your production:

  • World-class LIMS batch record traceability recorded for every GMP oligo
  • ISO 14644 Class 8 certified production, processing and final fill labs
  • Hard-copy analytical documentation for QC provided with each oligo
  • Long-term quality agreements and contracts available to ensure years of stable GMP oligo supply

We offer a full range of final-fill, labeling and OEM solutions with services including:

  • Customer-specified concentration formulations
  • Oligo mixes
  • Custom packaging and labeling
  • OEM and kitting solutions
  • Custom large scale synthesis from nmol to several grams
  • Plate packaging
  • Functional QC